(Dow Jones) - “Tysabri...caused 22 suspected cases of a rare brain infection through early October...a level deemed unalarming by physicians. Biogen didn't dispute the figures but has declined to disclose the number of suspected cases, arguing it doesn't help physicians and patients...”
This comes from an investigative news piece published yesterday. As of this writing, it wasn’t picked up by AP or Reuters, but it did prompt heated discussion among investors.
“Wall Street, though, has sought more information about the number of suspected PML cases in order to better assess the drug's future prospects, considered key for both companies. Analysts and investors have questioned Biogen's reticence to disclose more.”
On August 1, 2008, I listened to the conference call which Biogen/Elan conducted following the announcement of two confirmed cases of PML in Europe. At that time, representatives would not answer direct questions as to the number of suspected cases; they wouldn’t even reveal the gender nor country of the two patients reported.
During the call, I contemplated these questions: “How many patients are suspected of developing PML and taken off Tysabri? What are the more common, but unexpected, side-effects which have been noted in post-marketing surveillance? What is the drop-out rate?”
With the TOUCH protocol in the US and TYGRIS in Europe, these should be easy questions. However, they went unanswered, which is likely the impetus of the Dow Jones article.
For me, the PERCEIVED RISK of Tysabri is important both as an MS patient and as a patient advocate. Knowing out of 22 suspected cases of PML in about 26 months, that 2 had been confirmed and 1 was later confirmed, helps me in putting the risk in perspective.
However the investors did not see it that way. “It’s got to a point where patients are scared of Tysabri. It’s a mistake to assume that MS patients are well informed, because most are anything but. They are totally vulnerable to the spinners and moneymakers.”
So most MS patients are not well-informed, are scared, and thus vulnerable to PR slant. Huh? Well, maybe that’s true to some extent. But are these shareholders just angry that media might be used to fear-monger, which results in a lower stock price?
Something of which I was not previously aware is that Elan has a patient-driven strategy in place for promoting Tysabri, according to discussion on the investment board.
Have you encountered any Tysabri evangelists online? I have. Those patient advocates are key to the marketing efforts of promoting Tysabri. Funny thing is - patients are not bound by the same FDA regulations in drug promotion that companies are. How does that fit into the big picture?
I realize that this post is a bit rambling, but I have one more thing to add. There is a website called PatientsLikeMe which offers patients a place to record symptoms and treatment. It also features an active forum where patients discuss all sorts of topics, especially popular are the ‘off-topic’ topics. They also openly inform patients that their (unidentified) information will be used in research initiatives.
On November 3, 2008, PatientsLikeMe issued a report - “Did the July 2008 PML announcement affect the Tysabri brand?” (click on the title for a pdf of the report) One needs permission “to reproduce, repost, republish and/or redistribute PatientsLikeMe reports or information therein.” And - “With prior written permission, you may have an opportunity to use PatientsLikeMe reports and information to support marketing, business development, and other company initiatives."
Why do I care what the report says regarding the sentiments of MS patients? Well, conversation can be led by a few influential participants, and in this case, that holds true. What if one of the Tysabri advocates is in place to reduce the expressed fears by other MS patients? What if another of the Tysabri advocates endlessly talks down the perceived risks involved in this treatment choice?
How does a report, of which the data analyzed is potentially tainted by shareholders (who happen to also be patients on the drug therapy), be taken seriously? During a conversation, if many participants are very agressive in their praise of a product, so much so that they are spending enormous effort putting out the fires of fear, would YOU be more willing to express a contradictory opinion on the product in question?
No? I wouldn’t either....and that further skews the data to be analyzed.
I don’t really know what my point is today. But that we must remain vigilant and protect ourselves with reliable information and clarity of thought. There are too many interests involved in the world which is the Market for MS drugs. We are a rather large, and expensive (or rather profitable) group of people who sincerely want an improved quality of life and protected future.
So please, join me in reading as much as you can and stay informed. When you find something especially important to share, PLEASE DO!!!!!